The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Impax Diagnostic Display Station,impax Clinical Review Station,impax For Cardiology Clinical Review Satation,impax Ortho.
| Device ID | K022292 |
| 510k Number | K022292 |
| Device Name: | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA CORP. PO BOX 1927 Brevard, NC 28712 |
| Contact | David Ledwig |
| Correspondent | David Ledwig AGFA CORP. PO BOX 1927 Brevard, NC 28712 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-15 |
| Decision Date | 2002-09-12 |
| Summary: | summary |